Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: The Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial)

被引：135

作者：

Bansilal, Sameer ^{[1
]}

Bloomgarden, Zachary ^{[1
]}

Halperin, Jonathan L. ^{[1
]}

Hellkamp, Anne S. ^{[2
]}

Lokhnygina, Yuliya ^{[2
]}

Patel, Manesh R. ^{[2
]}

Becker, Richard C. ^{[3
]}

Breithardt, Guenter ^{[4
]}

Hacke, Werner ^{[5
]}

Hankey, Graeme J. ^{[6
]}

Nessel, Christopher C. ^{[7
]}

Singer, Daniel E. ^{[8
,9
]}

Berkowitz, Scott D. ^{[10
]}

Piccini, Jonathan P. ^{[2
]}

Mahaffey, Kenneth W. ^{[11
]}

Fox, Keith A. A. ^{[12
,13
]}

机构：

[1] Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[2] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC USA

[3] Univ Cincinnati, Coll Med, Cincinnati, OH USA

[4] Univ Hosp Munster, Div Electrophysiol, Dept Cardiovasc Med, Munster, Germany

[5] Heidelberg Univ, Heidelberg, Germany

[6] Univ Western Australia, Sch Med & Pharmacol, Crawley, Australia

[7] Janssen Res & Dev, Raritan, NJ USA

[8] Massachusetts Gen Hosp, Boston, MA 02114 USA

[9] Harvard Univ, Sch Med, Boston, MA USA

[10] Bayer HealthCare Pharmaceut, Whippany, NJ USA

[11] Stanford Univ, Dept Med, Stanford, CA 94305 USA

[12] Univ Edinburgh, Edinburgh, Midlothian, Scotland

[13] Royal Infirm Edinburgh NHS Trust, Edinburgh, Midlothian, Scotland

来源：

AMERICAN HEART JOURNAL | 2015年 / 170卷 / 04期

关键词：

RISK; MELLITUS; WARFARIN; THERAPY;

D O I：

10.1016/j.ahj.2015.07.006

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Background The prevalence of both atrial fibrillation (AF) and diabetes mellitus (DM) are rising, and these conditions often occur together. Also, DM is an independent risk factor for stroke in patients with AF. We aimed to examine the safety and efficacy of rivaroxaban vs warfarin in patients with nonvalvular AF and DM in a prespecified secondary analysis of the ROCKET AF trial. Methods We stratified the ROCKET AF population by DM status, assessed associations with risk of outcomes by DM status and randomized treatment using Cox proportional hazards models, and tested for interactions between randomized treatments. For efficacy, primary outcomes were stroke (ischemic or hemorrhagic) or non-central nervous system embolism. For safety, the primary outcome was major or nonmajor clinically relevant bleeding. Results The 5,695 patients with DM (40%) in ROCKET AF were younger, were more obese, and had more persistent AF, but fewer had previous stroke (the CHADS(2) score includes DM and stroke). The relative efficacy of rivaroxaban and warfarin for prevention of stroke and systemic embolism was similar in patients with (1.74 vs 2.14/100 patient-years, hazard ratio [HR] 0.82) and without (2.12 vs 2.32/100 patient-years, HR 0.92) DM (interaction P = .53). The safety of rivaroxaban vs warfarin regarding major bleeding (HRs 1.00 and 1.12 for patients with and without DM, respectively; interaction P = .43), major or nonmajor clinically relevant bleeding (HRs 0.98 and 1.09; interaction P = .17), and intracerebral hemorrhage (HRs 0.62 and 0.72; interaction P = .67) was independent of DM status. Adjusted exploratory analyses suggested 1.3-, 1.5-, and 1.9-fold higher 2-year rates of stroke, vascular mortality, and myocardial infarction in DM patients. Conclusions and Relevance The relative efficacy and safety of rivaroxaban vs warfarin was similar in patients with and without DM, supporting use of rivaroxaban as an alternative to warfarin in diabetic patients with AF.

引用

页码：675 / +

页数：16

共 16 条

[1]

Comparison of dabigatran versus warfarin in diabetic patients with atrial fibrillation: Results from the RE-LY trial [J].